Cleared Traditional

K142643 - Stabilynx PEEK Suture Anchor

K142643 is an FDA 510(k) clearance for Stabilynx PEEK Suture Anchor, manufactured by D3 Dc, LLC /Stabilynx, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K142643 · D3 Dc, LLC /Stabilynx, Inc. · Orthopedic device
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Dec 2014
Decision
89d
Days
Class 2
Risk

K142643 is an FDA 510(k) clearance for the Stabilynx PEEK Suture Anchor. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by D3 Dc, LLC /Stabilynx, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all D3 Dc, LLC /Stabilynx, Inc. devices

FDA 510(k) Submission Details - K142643

510(k) Number K142643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2014
Decision Date December 15, 2014
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K142643.
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
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Extremity Medical Suture Anchor
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4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
K142574 · Depuy Mitek, A Johnson & Johnson Company · Oct 2014
G-Lok and G-Lok XL Extender
K142653 · T.A.G. Medical Products Corporation, Ltd. · Oct 2014
Apollo Suture Anchor System and Titan Screws
K142230 · Valeris Medical · Sep 2014